A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Two-Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 as a Treatment for Adults With At Least Moderately Active Systemic Lupus Erythematosus

TerminadoFase 2ClinicalTrials.gov

ID: NCT05123586Tipo: INTERVENTIONALInicio: 7 de mar de 2022Fin estimado: 29 de dic de 2023

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus (SLE). Study will last up to 34 weeks and may include up to 15 visits.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Are diagnosed with SLE at least 24 weeks before Day 1 of study
Have documentation of having a score of 10 or more points on the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE
Have a SLEDAI-2K score ≥6 at screening (Day 1) and clinical Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥4 (not including any items related to laboratory values) at randomization (Day 2)
Must be receiving at least 1 background standard-of-care medication for SLE

Criterios de exclusión

Participants are excluded if they have received any of the following medications or therapies within the indicated timeframe prior to the randomization visit (Day 2).
Are currently receiving oral corticosteroids at doses \>20 mg per day of prednisone (or equivalent) or have adjusted the dosage of corticosteroids within 2 weeks before starting study treatment
Have received parenteral corticosteroids within 12 weeks before starting study treatment or are expected to require parenteral corticosteroids during the study
Have a current or recent acute, active infection
Have had a serious, chronic, recurring conditions of herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis)
Have human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV), hepatitis C infection (HCV), active tuberculosis (TB)
Have active fibromyalgia or active occurrence of an inflammatory condition that, in the investigator's opinion, would make it difficult to appropriately assess SLE activity for the purposes of this study
Have experienced a cardiac event within 24 weeks to 12 months prior to screening
Have a history of clinically significant or uncontrolled illness that in the opinion of the investigator could put the participant at risk to participate in the study
Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide
Are pregnant or are intending to become pregnant or to breastfeed at any time in the study

Intervenciones

drug

LY3361237

Administered SC

drug

Placebo

Administered SC

Ubicaciones

Clínica Privada Independencia

Munro, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires, Argentina

APRILLUS Asistencia E Investigacion

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Instituto de Investigaciones Clinicas Zarate

Zárate, Santa Fe Province, Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, Argentina

APRILLUS Asistencia E Investigacion

Ciudad Autónoma de Buenos Aire, Argentina

DOM Centro de Reumatología

Ciudad Autónoma de Buenos Aire, Argentina

CENUDIAB

Ciudad Autónoma de Buenos Aire, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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